exempt, expedited, and greater than minimal risk

Exempt research includes: work evaluating educational practices in established educational settings as well as

survey, interview, or observational procedures where subjects are not identified or public behavior is being observed

IRBs will expedite research that presents

minimal risk to participants or involves a minor revision to an already approved protocol

Greater than minimal risk research

may pose substantial risk to participants and requires a full institutional review board review.

STEPS IN THE IRB PROCESS

ethics training, preparation of the proposal, and submission of the proposal to the IRB

Step 2: Prepare Proposal

get to know IRB staff members and work with rather than against them

A brief summary that outlines the specific aims of your research and why the research is important.

The use of open-ended and exploratory methodology, which focuses on gathering in depth information on topics of interest.

Quantitative research

The use of numerical data and statistical techniques to examine questions of interest.

clearly explain the importance of proposed research,

since even exploratory/qualitative research is arguably grounded in a goal of examining specific research questions.

Protocol document: summarizes an intended research project, including

the specific aims, background and importance, participants, methods, and predicted results.

provide only a basic outline of the research project that

focuses on issues related to the protection of human subjects

giving a general description of the stimuli may help you

avoid having to send a revised IRB application every time you decide to alter the stimuli later

Identification of Participants

number, recruiting, inclusion and exclusion criteria, subject selection should be equitable,

subject selection should be equitable

socioeconomically and racially diverse participants and not rely on a single population (i.e.,upper-middle-class people,men)

recruitment should be noncoercive; participation should be

clearly voluntary, and the recruiting process should respect the autonomy of participants.

Often IRBs will request copies of

flyers, e-mails, and phone scripts that will be used to recruit participants.

it is usually better to overestimate the number of participants you will include in your research because IRBs do not like

it when you exceed the number tor which you have been approved

collecting more data than expected is considered

a violation of research protocol

Agreement of a participant to take part in a study, having been made aware of the potential risks.

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Negotiating the Institutional Review Board Process

Term	Definition
TYPE OF IRB REVIEW	exempt, expedited, and greater than minimal risk
Exempt research includes: work evaluating educational practices in established educational settings as well as	survey, interview, or observational procedures where subjects are not identified or public behavior is being observed
IRBs will expedite research that presents	minimal risk to participants or involves a minor revision to an already approved protocol
Greater than minimal risk research	may pose substantial risk to participants and requires a full institutional review board review.
STEPS IN THE IRB PROCESS	ethics training, preparation of the proposal, and submission of the proposal to the IRB
Step 1: Complete Ethics Training	get online cirtificate
Step 2: Prepare Proposal	get to know IRB staff members and work with rather than against them
Abstract	A brief summary that outlines the specific aims of your research and why the research is important.
Qualitative research	The use of open-ended and exploratory methodology, which focuses on gathering in depth information on topics of interest.
Quantitative research	The use of numerical data and statistical techniques to examine questions of interest.
clearly explain the importance of proposed research,	since even exploratory/qualitative research is arguably grounded in a goal of examining specific research questions.
Protocol document: summarizes an intended research project, including	the specific aims, background and importance, participants, methods, and predicted results.
provide only a basic outline of the research project that	focuses on issues related to the protection of human subjects
giving a general description of the stimuli may help you	avoid having to send a revised IRB application every time you decide to alter the stimuli later
Identification of Participants	number, recruiting, inclusion and exclusion criteria, subject selection should be equitable,
subject selection should be equitable	socioeconomically and racially diverse participants and not rely on a single population (i.e.,upper-middle-class people,men)
recruitment should be noncoercive; participation should be	clearly voluntary, and the recruiting process should respect the autonomy of participants.
Often IRBs will request copies of	flyers, e-mails, and phone scripts that will be used to recruit participants.
it is usually better to overestimate the number of participants you will include in your research because IRBs do not like	it when you exceed the number tor which you have been approved
collecting more data than expected is considered	a violation of research protocol
inflate your subject number by	at least 50%
running additional participants may	increase the overall risk
Informed consent	Agreement of a participant to take part in a study, having been made aware of the potential risks.

Created by: james22222222

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